Monitoring Adverse Gastrointestintal Events In Cow’s Milk Immunotherapy Using the Esophageal STRING Test (MAGIC-STRING)

Overview

About this study

The primary objective of this study is to evaluate markers of eosinophilic inflammation in the esophagus longitudinally in subjects on milk oral immunotherapy (OIT) or placebo.

This is a companion study to a parent clinical trial which is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in subjects aged 4 to 50 years inclusive who are allergic to milk. The parent study consists of a screening period, a 24-week treatment period, which includes 4 weeks of pre-treatment with dupilumab or placebo followed by 12 weeks of treatment with dupilumab or placebo in combination with a gradual up-dosing of milk protein OIT, then followed by 8 weeks of milk OIT dosing with no dupilumab or placebo.  This study will examine markers of esophageal inflammation during the parent study using a non-invasive testing device, the esophageal string test (EST).

No dupilumab data will be reported to the FDA for this string test study.

The EnteroTracker® is an FDA-registered and listed Class I, 510(k) exempt medical device which is available for sale and use in the United States.  While is currently marketed for diagnosis and monitoring of EoE, the device (i.e. string test) itself was initially developed and used for detection of giardia infection and collection of duodenal bile and was referred to as the Entero-Test.  Enterotracker® combines the string test device with Lab-Developed Tests (LDTs) for EoE-associated disease biomarkers validated under CAP/CLIA standards (LDTs performed by Cambridge Biomedical Inc. CAP Accreditation (LAP# 7191028) CLIA Accreditation (ID# 22D0926993) FDA Registration (3003006583)).

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Enrolled in companion study (MAGIC).
  • Must be able to swallow esophageal string test (EST).

Exclusion Criteria:

  • Any exclusion criteria from the companion study (MAGIC).
     

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Benjamin Wright, M.D.

Open for enrollment

Contact information:

Temeka Simmons

(480) 301-9224

Simmons.Temeka@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20520137

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